Clearance Summary
NOVEL VBR SPINAL SYSTEM received FDA 510(k) clearance under submission number K042201, sponsored by Alphatec/Nexmed. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-10-07.
- Submission: K042201
- Applicant / Sponsor: Alphatec/Nexmed
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2004-10-07
Classification & Regulation
This clearance is catalogued under FDA product code MQP and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.